| 陈子桃,赖云锋,陈新林,许星莹,张桂兰,徐梦丹.基于上市许可持有人的药品不良反应主动监测模式的构建与评估研究[J].中国药事,2024,38(3):261-268 |
| 基于上市许可持有人的药品不良反应主动监测模式的构建与评估研究 |
| Research on the Construction and Evaluation of Active Monitoring Model ofAdverse Drug Reactions by Marketing Authorization Holder |
| 投稿时间：2023-11-05 |
| DOI：10.16153/j.1002-7777.2024.03.004 |
| 中文关键词: 上市许可持有人 药品不良反应 主动监测 模式构建 中国医院药物警戒系统 |
| 英文关键词: marketing authorisation holder adverse drug reaction active monitoring model construction Chinese Hospital Pharmacovigilance System |
| 基金项目:广东省药品监督管理局2022年科技创新项目（编号 2022ZDZ06）；广东省中医药局项目（编号 20204003）； 广东省哲学社会科学规划项目（编号 GD23SQGL01）；广东省教育科学规划课题（编号 2022GXJK060）；广东省基础与应用基础研究基金项目（编号 2022A1515220162）；广东省基础与应用基础研究基金项目（编号 2022A1515220148） |
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| 中文摘要: |
| 目的：探讨药品上市许可持有人（Marketing Authorization Holder，MAH）的药品不良反应主动监测创新模式的构建及其效果评估，为落实MAH药物警戒主体责任提供实证参考。方法：首先针对MAH药物警戒的现存挑战，基于中国医院药物警戒系统（Chinese Hospital Pharmacovigilance System，CHPS）设计MAH针对药品不良反应的主动监测模式，包括不良反应的监测、识别、评估及控制；再以注射用卡瑞利珠单抗为例分析主动监测效果。结果与结论：从MAH视角，构建基于CHPS整合循证证据和真实世界数据开展ADR主动监测的创新模式，包括运行模式、数据挖掘及模型构建。该主动监测模式被成功应用到以卡瑞利珠单抗为例的临床实践中，取到良好的效果。该研究成果不仅能帮助MAH开展药品监测工作，落实药品全生命周期主体责任，还能丰富药物警戒的内涵，为促进药物警戒发展和合理用药提供具有可操作性的实证参考。 |
| 英文摘要: |
| Objective: To explore the construction and evaluation of active monitoring innovation modelof adverse drug reactions by marketing authorization holder (MAH), to provide empirical reference forimplementing the main responsibility of MAH pharmacovigilance. Methods: For the existing challenges ofMAH pharmacovigilance, an active monitoring model for MAH adverse drug reactions was designed based onthe Chinese Hospital Pharmacovigilance System (CHPS), including the monitoring, identification, evaluationand control of adverse reactions. Camrelizumab was used as an example to analyze the eff ectiveness of activemonitoring. Results and Conclusion: From the perspective of MAH, this study design an innovation model for active monitoring of ADR based on CHPS integrating evidence-based evidence and real-world data, includingoperation mode, data mining and model design. This active monitoring model has been successfully applied inclinical practice represented by camrelizumab, and achieves good results. The research can not only help MAHto carry out drug monitoring work and implement the main responsibilities of the entire life cycle of drugs, butalso enrich the connotation of pharmacovigilance and provide practical empirical reference for promoting thedevelopment of pharmacovigilance and rational drug use. |
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